General MedicationsTOPICALStandard
AZELEX
AZELAIC ACID
Standard Dose
20%
Max Dose
Refer to approved labeling
Primary Use
Review priority: STANDARD Marketing status: Prescription
Summary
Approval overview AZELEX is listed in Drugs@FDA under application 020428 (NDA).
Review priority: STANDARD Marketing status: Prescription Active ingredient AZELAIC ACID Form and strength CREAM;TOPICAL - 20% Sponsor ALMIRALL Submission history Latest submission status date: 2024-02-20 00:00:00.
Structured Monograph
Clinical summary
Approval overview AZELEX is listed in Drugs@FDA under application 020428 (NDA). Review priority: STANDARD Marketing status: Prescription Active ingredient AZELAIC ACID Form and strength CREAM;TOPICAL - 20% Sponsor ALMIRALL Submission history Latest submission status date: 2024-02-20 00:00:00. Submission type: SUPPL.
Monitoring
- • Marketing status: Prescription
- • Review priority: STANDARD
Interaction Notes
- No interaction notes stored yet.